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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003848
Receipt No. R000004635
Scientific Title Effects of intravenous beta-blocker(landiolol) infusion after percutaneous coronary intervention for acute myocardial infarction patients.
Date of disclosure of the study information 2010/08/01
Last modified on 2014/07/01

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Basic information
Public title Effects of intravenous beta-blocker(landiolol) infusion after percutaneous coronary intervention for acute myocardial infarction patients.
Acronym Benefit-study
Scientific Title Effects of intravenous beta-blocker(landiolol) infusion after percutaneous coronary intervention for acute myocardial infarction patients.
Scientific Title:Acronym Benefit-study
Region
Japan

Condition
Condition Acute myocardial infarction
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluate the effect of landiol on infarct size and clinical outcomes after percutaneous coronary intervention for acute myocardial infarction patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes estimated infarct size
Key secondary outcomes 1)Left ventricular ejection fraction
2)inflammatory markers
3)MACE

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intravenous landiolol infusion
Interventions/Control_2 Placebo
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients with first ST elevation myocardial infarction within 12 hours from onset, who underwent successful emergency PCI resulting in TIMI3 flow.
Key exclusion criteria 1)History of old myocardial infarction or CABG
2)Left main coronary artery disease
3)Contraindication of landiolol
4)Contraindication of oral beta-blocker therapy
5)Contraindication of aspirin
6)Systolic blood pressure is 80mmHg or lower
7)Heart rate is 60/min or lower due to atrioventricular block etc.
8)Patients already taking beta-blocker
9)Severe renal and liver dysfunction
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshihiko Nishioka, MD
Organization Saitama Medical Center, Saitama Medical University
Division name Division of Cardiology
Zip code
Address 1981 Kamoda, Kawagoe, Saitama, Japan
TEL 049-228-3400
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Toyama, MD
Organization Saitama Medical Center, Saitama Medical University
Division name Division of Cardiology
Zip code
Address 1981 Kamoda, Kawagoe, Saitama, Japan
TEL 049-228-3400
Homepage URL
Email

Sponsor
Institute Division of Cardiology, Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 埼玉医科大学総合医療センター

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 07 Month 21 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 06 Month 30 Day
Last modified on
2014 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004635

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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